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SeaStar Medical Begins Shipping QUELIMMUNE to a Fourth Hospital Customer
DENVER, Jan. 08, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company developing proprietary
About this update from Seastar Medical Holding Corporation
[{"type":"text","content":"DENVER, Jan. 08, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces the shipment of its QUELIMMUNE™ device to a prominent academic medical center, representing SeaStar Medical’s fourth commercial customer. QUELIMMUNE is the company’s Selective Cytopheretic Device (SCD) for treating critically ill children in the intensive care unit (ICU) with acute kidney injury (AKI) and sepsis. “We are pleased to expand commercial access to QUELIMMUNE and are extremely proud to be the only company to develop and commercialize a therapeutic device that has demonstrated clinical results to reduce mortality and decrease dialysis dependency in these severely ill children,” said Tim Varacek, SeaStar Medical Senior Vice President, Commercial & Business Operations. “In addition to compelling clinical benefits, QUELIMMUNE’s ability to reduce healthcare costs is another reason for hospitals to adopt our therapeutic device,” said Eric Schlorff, SeaStar Medical CEO. “Our data show that AKI patients treated with the SCD had no dialysis dependency 60 days after treatment. Because the cost for a single patient on dialysis is about $100,000 per year, eliminating this cost represents a substantial and ongoing savings to the healthcare system. QUELIMMUNE also has the potential to reduce the average length of hospital stay and to lower the rate of readmissions and post-acute emergency visits. Of note, the average hospital cost per pediatric ICU patient with AKI including those with sepsis requiring continuous renal replacement therapy exceeds $350,000.” QUELIMMUNE is being commercialized following U.S. Food and Drug Administration (FDA) approval for children with AKI and sepsis or septic condition weighing 10 kilograms or more who are being treated in the ICU with renal replacement therapy (RRT). QUELIMMUNE was approved under a Humanitarian Device Exemption (HDE) application, having met the applicable criteria with clinical results showing safety and probable clinical benefit in a limited population of critically ill children with AKI who have few treatment options. Acute Kidney Injury (AKI) and Hyperinflammation AKI is characterized by a sudden and temporary loss of kidney function and ca...